A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Crohn's Disease
In brief
The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 52 (US/FDA and EU/EMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA). Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA).
Key facts
- Study ID
- NCT06430801
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 1200
- Starts
- 2024-06-05
- Expected to finish
- 2029-11-12
- Last updated by the study team
- 2026-08-07
Who can join
Age: 16 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Has had a diagnosis of Crohn's disease (CD) at least 3 months before study.
- Has moderately to severely active CD.
- Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and/or small molecule advanced therapies.
- Adolescent participants ≥16 and <18 years of age can participate if approved by the country or regulatory/health authority.
You may not qualify if…
- Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.
- Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement.
- Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.
- Has current stoma or need for colostomy or ileostomy.
- Is missing >2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.
- Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides CD.
- Has surgical bowel resection within 3 months of study.
- Has prior or current gastrointestinal dysplasia.
- Has chronic infection requiring ongoing antimicrobial treatment.
- Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for <5 years.
- Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
- Has active tuberculosis.
- Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection.
- Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-tumor necrosis factor-like cytokine 1A (TL1A) antibody (Ab).
Where it is running
- Endoscopic Research Inc ( Site 5061) — Orlando, Florida, United States (enrolling)
- Covenant Metabolic Specialists, LLC ( Site 5143) — University Park, Florida, United States (enrolling)
- Sanchez Clinical Research ( Site 5144) — Miami, Florida, United States (enrolling)
- AdventHealth Orlando ( Site 5131) — Orlando, Florida, United States (enrolling)
- USF Health Carol and Frank Morsani Center for Advanced Healthcare ( Site 5039) — Tampa, Florida, United States (enrolling)
- GI Alliance - Sun City ( Site 5118) — Sun City, Arizona, United States (enrolling)
- Om Research LLC ( Site 5038) — Lancaster, California, United States (enrolling)
- University of Arizona Clinical and Translational Sciences Research Center ( Site 5111) — Tucson, Arizona, United States (enrolling)
- UCLA Clinical & Translational Research Center (CTRC) ( Site 5116) — Los Angeles, California, United States (enrolling)
- University of Arkansas for Medical Sciences ( Site 5147) — Little Rock, Arkansas, United States (enrolling)
- Clinnova Research ( Site 5110) — Anaheim, California, United States (enrolling)
- Clinical Applications Laboratories ( Site 5123) — San Diego, California, United States (enrolling)
- Southern California Research Center ( Site 5044) — Coronado, California, United States (enrolling)
- University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 5026) — Aurora, Colorado, United States (enrolling)
- Peak Gastroenterology Associates ( Site 5023) — Colorado Springs, Colorado, United States (enrolling)
- South Denver Gastroenterology, PC ( Site 5132) — Englewood, Colorado, United States (enrolling)
- Rocky Mountain Gastroenterology ( Site 5082) — Lakewood, Colorado, United States (enrolling)
- Cedars Sinai Medical Center ( Site 5080) — Los Angeles, California, United States (enrolling)
- Yale University School of Medicine-Digestive Disease ( Site 5019) — New Haven, Connecticut, United States (enrolling)
- Emerson Clinical Research Institute ( Site 5051) — Washington D.C., District of Columbia, United States (enrolling)
- University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 5128) — Orange, California, United States (enrolling)
- Covenant Metabolic Specialists, LLC ( Site 5150) — Fort Myers, Florida, United States (enrolling)
- Nature Coast Clinical Research - Inverness ( Site 5042) — Inverness, Florida, United States (enrolling)
- Om Research LLC ( Site 5045) — Oxnard, California, United States (enrolling)
- Morehouse School Of Medicine ( Site 5071) — Atlanta, Georgia, United States (enrolling)
Full record on ClinicalTrials.gov
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